The Cosmetic Act is issued by the Pharmaceutical and Medical Devices Agency (PMDA) of Japan, and it is supported by a series of subsidiary rules, standards and guidance documents issued by the competent authority, Ministry of Health, Labour and Welfare (MHLW). The main regulations concerning cosmetics in Japan are “Pharmaceutical and Medical Device Law” and “Standards for Cosmetics”
There are more than 10 Existing Key Cosmetic Regulations in force, for example, “Act for Ensuring Quality, Effectiveness, and Safety of Pharmaceutical and Medical Devices”, which came into force on September 14th, 2019.
According to Article 2.3 of the Pharmaceutical Affairs Law, “cosmetics” is defined as articles with mild action on the human body which are intended to be applied to the human body through rubbing, sprinkling or other similar methods, aiming to clean, beautify and increase the attractiveness, alter the appearance or to keep the skin or hair in good condition.
Cosmetic products include two main categories in Japan.
The common quasi-drugs product types in Japan include the following:
A thorough documentation of the active ingredient should be provided to the Pharmacy agency: Pre-Marketing Registration and Approval (PMDA). The agency will fully verify the product and claimed effects and then a specific labelling with the term "quasi drug" will be provided. A monograph is possible to follow for certain products.
"The ingredients of cosmetic products, including the impurities they contain, must not contain anything that could cause infection or make the use of cosmetic products hazardous to health” --Standard for Cosmetics
To help the manufacturers with their formulation, the Cosmetic Act has establish the following documents :
The Label and claims
The labelling should be in Japanese and present the following :
"Codes on Fair Competition regarding the representations of cosmetics" are Volontary standards on labelling and claims which are widely observed in Japan.
A list of 56 accepted efficacy claims for cosmetics is establish to prevent companies from giving unreasonable premiums and misleading representations claims. The Cosmetic Act :